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A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
Sponsor: BeOne Medicines
Summary
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
Official title: A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
614
Start Date
2021-09-13
Completion Date
2029-11
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
BGB-16673
Orally administered
Locations (120)
University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
Mayo Clinic Phoenix
Phoenix, Arizona, United States
Honor Health Research Institute
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, United States
Stanford Medicine
Palo Alto, California, United States
UCLA Santa Monica Cancer Care
Santa Monica, California, United States
Uchealth North
Fort Collins, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Tampa General Hospital Cancer Institute
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
Southeastern Regional Medical Center
Newnan, Georgia, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
American Oncology Partners of Maryland Pa
Bethesda, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Tennesse Oncology Chattanooga Downtown
Chattanooga, Tennessee, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States
Md Anderson Cancer Center
Houston, Texas, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Perth Blood Institute
West Perth, Western Australia, Australia
Hospital Sirio Libanes Brasilia
Brasília, Brazil
Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul
Caxias do Sul, Brazil
Hospital Erasto Gaertner
Curitiba, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Brazil
Real E Benemerita Associacao Portuguesa de Sao Paulo
São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
Hospital Nove de Julho Dasa
São Paulo, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil
Arthur Je Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, Canada
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Yichang Central Peoples Hospitaljiangnan Branch
Yichang, Hubei, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, France
Hopital Estaing
Clermontferrand, France
Chu Henri Mondor
Créteil, France
Hopital Claude Huriez Chu Lille
Lille, France
Centre Leon Berard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Chu Montpellier Hopital Saint Eloi
Montpellier, France
Hopital de La Pitie Salpetriere
Paris, France
Centre Henri Becquerel
Rouen, France
Arensia Exploratory Medicine Llc
Tbilisi, Georgia
Uniklinik Koeln (Aoer)
Cologne, Germany
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, Germany
Universitares Krebszentrum Leipzig
Leipzig, Germany
Universitaetsklinikum Schleswig Holstein Campus Luebeck
Lübeck, Germany
Klinikum Johannes Gutenberg Universitaet Mainz
Mainz, Germany
Klinikum Grosshadern Ludwig Maximilians Universitat Munchen
München, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, Italy
Ospedale San Raffaele
Milan, Italy
Istituto Europeo Di Oncologia
Milan, Italy
Niguarda Cancer Center Division of Hematology
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy
Centroricerche Cliniche Di Verona Srl
Verona, Italy
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, Japan
Chiba Cancer Center
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, Japan
Yokohama Municipal Citizens Hospital
Yokohama, Japan
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, Moldova
Inje University Busan Paik Hospital
BusanjinGu, Busan Gwang'yeogsi, South Korea
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Hospital Universitario Vall Dhebron
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Md Anderson Cancer Center Madrid Spain
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Sahlgrenska University Hospital Hematology
Gothenburg, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden
Dokuz Eylul University
Balçova, Turkey (Türkiye)
Erciyes University
Kayseri, Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, Turkey (Türkiye)
Ondokuz Mayis University
Samsun, Turkey (Türkiye)
Edinburgh Cancer Centre
Edinburgh, United Kingdom
St Jamess University Hospital
Leeds, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom